MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM; GROWING ROD SYSTEM-MAGNETIC ACTUATION

Model Number RA002-4545SL70, RA002-4545SLR70

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

The patient was implanted with dual magec rods (lot# a140919-05-00; manufacture date 09/01/2014, expiration date 09/01/2016, and lot# a140812-01-00; manufacture date 08/01/2014, expiration date 08/01/2016), and it was alleged that the rods appear to not be distracting.The rods were removed on (b)(6) 2016, and the patient was implanted with new dual magec rods without incident.To date, the patient is doing fine and no negative outcomes have been reported.A dhr review revealed that the rods met all of the required quality inspections and were released within specifications.

Event Description

A distributor reported that a surgeon alleged that a patient's dual magec rods appear to not be distracting after two (2) years of implantation.

Manufacturer Narrative

This supplemental report was sent to update the mfr report number.Supplemental 3001679046-2016-00039-1 was submitted under the incorrect report number.

• Brand Name: MAGEC® SPINAL BRACING AND DISTRACTION SYSTEM
• Type of Device: GROWING ROD SYSTEM-MAGNETIC ACTUATION
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise; suite 100; aliso viejo CA 92656
• Manufacturer Contact: john mcintyre ; 101 enterprise; suite 100; aliso viejo, CA 92656 ; 9498373600
• MDR Report Key: 6110231
• MDR Text Key: 60252363
• Report Number: 3006179046-2016-00039
• Device Sequence Number: 1
• Product Code: PGN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: RA002-4545SL70, RA002-4545SLR70
• Device Lot Number: A140919-05-00, A140812-01-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/06/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 8 YR